NCT03453983

Brief Summary

Transcrainial direct current stimulation (tDCS) has become increasingly popular over the past decade. tDCS is a safe and well-studied form of non-invasive brain stimulation. The purpose of the current study is to see if tDCS can improve motor function in children with developmental coordination disorder. Non-invasive brain stimulation is shown to positively affect motor performance in children with neurodevelopmental and/or neurological conditions. For example, tDCS improves hand motor function in children with paediatric stroke and cerebral palsy. The benefits of tDCS in developmental coordination disorder is unknown. The current study will assess children's motor performance before and after tDCS intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

March 25, 2020

Status Verified

April 1, 2019

Enrollment Period

1.5 years

First QC Date

February 27, 2018

Last Update Submit

March 23, 2020

Conditions

Developmental Coordination Disorder

Keywords

NeurodevelopmentPediatricsMotor LearningBrain ImagingNeuroscience

Outcome Measures

Primary Outcomes (1)

  • Purdue Pegborad Test (PPT)

    The PPT is a valid measure of fine motor coordination, hand dexterity, and motor learning skills, which consists of 4 subtests: left hand peg placement \[PPTL\], right hand peg placement \[PPTR\], bimanual peg placement \[PPTLR\], and bimanual assembly \[PPTA\]. The PPT peg placement subtests involve placing as many pins as possible into a pegboard during a 30 second interval. The total number of pegs, or pairs of pegs, placed are counted and scored. The PPT assembly subtest involved building as many copies of a demonstration structure using pins, pegs, and washers within a 60 second time period.

    20 minutes

Secondary Outcomes (2)

  • Jebsen-Taylor Test of Hand Function (JTT)

    20 minutes

  • Serial Reaction Time Task (SRTT)

    20 minutes

Other Outcomes (1)

  • KINARM

    45 minutes

Study Arms (2)

Anodal tDCS Intervention Group

EXPERIMENTAL

Transcrainial Direct Current Stimulation (tDCS): The right primary motor cortex will be localized and a saline soaked sponge electrode will be placed onto M1 with a second saline soaked sponge electrode placed on the contralateral supraorbital region.

Device: Transcrainial Direct Current Stimulation (tDCS)

Sham tDCS Intervention Group

SHAM COMPARATOR

Transcrainial Direct Current Stimulation (tDCS): The right primary motor cortex will be localized and a saline soaked sponge electrode will be placed onto M1 with a second saline soaked sponge electrode placed on the contralateral supraorbital region.

Device: Transcrainial Direct Current Stimulation (tDCS)

Interventions

Transcrainial Direct Current Stimulation (tDCS)DEVICE

Transcranial direct current stimulation (tDCS) is a safe non-invasive form of brain stimulation, which modulates, through the application of weak direct current, cortical excitability. The applied subthreshold current passes through two externally placed electrodes, an anode and cathode.

Anodal tDCS Intervention GroupSham tDCS Intervention Group

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed and documented DCD (including individuals with additional diagnoses of attention and/or learning disorders)
  • Aged 10 to 15 years
  • Right Handed

You may not qualify if:

  • Presence of implanted electrical devices, metallic implants, and/or irremovable metal objects (i.e., cardiac pacemakers, braces etc.)
  • Pregnancy or possibility of pregnancy
  • Diagnosed with a neuropsychiatric disorder such as autism spectrum disorder or chronic medical condition such as cerebral palsy or epilepsy
  • Taking prescribed medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Development Center, Owerko Centre Alberta Children's Hospital

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (10)

  • Smits-Engelsman BC, Blank R, van der Kaay AC, Mosterd-van der Meijs R, Vlugt-van den Brand E, Polatajko HJ, Wilson PH. Efficacy of interventions to improve motor performance in children with developmental coordination disorder: a combined systematic review and meta-analysis. Dev Med Child Neurol. 2013 Mar;55(3):229-37. doi: 10.1111/dmcn.12008. Epub 2012 Oct 29.

    PMID: 23106530BACKGROUND

  • Reis J, Schambra HM, Cohen LG, Buch ER, Fritsch B, Zarahn E, Celnik PA, Krakauer JW. Noninvasive cortical stimulation enhances motor skill acquisition over multiple days through an effect on consolidation. Proc Natl Acad Sci U S A. 2009 Feb 3;106(5):1590-5. doi: 10.1073/pnas.0805413106. Epub 2009 Jan 21.

    PMID: 19164589BACKGROUND

  • Goodwill AM, Reynolds J, Daly RM, Kidgell DJ. Formation of cortical plasticity in older adults following tDCS and motor training. Front Aging Neurosci. 2013 Dec 6;5:87. doi: 10.3389/fnagi.2013.00087. eCollection 2013.

    PMID: 24367333BACKGROUND

  • Ciechanski P, Kirton A. Transcranial Direct-Current Stimulation Can Enhance Motor Learning in Children. Cereb Cortex. 2017 May 1;27(5):2758-2767. doi: 10.1093/cercor/bhw114.

    PMID: 27166171BACKGROUND

  • Kirton A, Ciechanski P, Zewdie E, Andersen J, Nettel-Aguirre A, Carlson H, Carsolio L, Herrero M, Quigley J, Mineyko A, Hodge J, Hill M. Transcranial direct current stimulation for children with perinatal stroke and hemiparesis. Neurology. 2017 Jan 17;88(3):259-267. doi: 10.1212/WNL.0000000000003518. Epub 2016 Dec 7.

    PMID: 27927938BACKGROUND

  • Kirton A, Andersen J, Herrero M, Nettel-Aguirre A, Carsolio L, Damji O, Keess J, Mineyko A, Hodge J, Hill MD. Brain stimulation and constraint for perinatal stroke hemiparesis: The PLASTIC CHAMPS Trial. Neurology. 2016 May 3;86(18):1659-67. doi: 10.1212/WNL.0000000000002646. Epub 2016 Mar 30.

    PMID: 27029628BACKGROUND

  • Moura RCF, Santos C, Collange Grecco L, Albertini G, Cimolin V, Galli M, Oliveira C. Effects of a single session of transcranial direct current stimulation on upper limb movements in children with cerebral palsy: A randomized, sham-controlled study. Dev Neurorehabil. 2017 Aug;20(6):368-375. doi: 10.1080/17518423.2017.1282050. Epub 2017 Feb 25.

    PMID: 28632467BACKGROUND

  • Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.

    PMID: 27372845BACKGROUND

  • Ambrus GG, Al-Moyed H, Chaieb L, Sarp L, Antal A, Paulus W. The fade-in--short stimulation--fade out approach to sham tDCS--reliable at 1 mA for naive and experienced subjects, but not investigators. Brain Stimul. 2012 Oct;5(4):499-504. doi: 10.1016/j.brs.2011.12.001. Epub 2012 Feb 22.

    PMID: 22405745BACKGROUND

  • Grohs MN, Craig BT, Kirton A, Dewey D. Effects of Transcranial Direct Current Stimulation on Motor Function in Children 8-12 Years With Developmental Coordination Disorder: A Randomized Controlled Trial. Front Hum Neurosci. 2020 Dec 11;14:608131. doi: 10.3389/fnhum.2020.608131. eCollection 2020.

    PMID: 33362497DERIVED

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Deborah M Dewey, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will not be informed of the stimulation group to which they are randomized. Both stimulation groups produce similar transient scalp sensations in participants and the sham protocol that will be used has been shown to be valid and ensures that participants are naïve to their assigned treatment group \[9\]. Participants will be asked which stimulation group they felt they took part in to ensure adequate blinding. Outcomes assessors will be blinded. Offline video analysis will be used to score motor assessment performance. These videos will exclude all identifying information including the participant's face and their stimulation group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The currently proposed study is a randomized, sham controlled clinical trial that includes 30 adolescents diagnosed with DCD. Participants will be randomized to one of two tDCS treatment groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 5, 2018

Study Start

June 1, 2018

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

March 25, 2020

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Currently, there is no pre-determined plan to share any collected data with other researchers.

Locations

CA(1)